Recognized standard
TIR 80001-2-4:2012 TR 80001-2-4 Edition 1.0 2012-11
FDA recognition 13-63 · IEC · Software/Informatics
Key facts
| Recognition number | 13-63 |
|---|---|
| Designation | TIR 80001-2-4:2012 TR 80001-2-4 Edition 1.0 2012-11 |
| Title | Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation… |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Software/Informatics |
| Date of entry | Jan 30, 2014 |
| Scope (excerpt) | IEC/TR 80001-2-4:2012(E), which is a technical report, provides guidance to help a healthcare delivery organization fulfilling its obligations as a responsible organization in the application of IEC 80001-1. A healthcare delivery organization includes hospitals, doctors' offices, community care… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: